Clinical Trial Medications: Environmental Monitoring From Start to Finish
Clinical trials are an important step when it comes to determining the impact of a new potential treatment. With strict oversight by Institutional Review Boards, clinical trials provide the FDA with the information needed to weigh the benefits and risks of a new medication and decide whether it is safe for patients.
The priority of every clinical trial is the safety of the patients participating. That means it is vital that the investigational medicine dispensed to the patient is in good condition and has been stored properly. It is essential that those performing the trial are able to control the temperature condition of the medications, as well as have visibility of any excursions prior to dispensation.
During a trial, medications are exposed to a multitude of environments during the entire process of packaging, shipping, and on-site in storage. It is imperative that all of the points in this process are monitored so that the appropriate people are alerted to any temperature excursions. Furthermore, it is also important that once in storage on site, staff can frequently monitor loggers in the fridges that store the medication.
Packaging a temperature logger in with the medication enables temperature tracking through shipment and storage. This end-to-end approach provides a temperature history of the medications. For example, the staff may unpack a shipment and leave the medications on the side for a period before placing in appropriate storage. The temperature of the room may cause an excursion causing the medications to become ineffective. With the data logging history, the staff can see when the excursion occurred and mark that shipment as unusable.
Most loggers being used today, including the DicksonOne data loggers, allow for viewing of real-time data from any mobile device, thus removing the need for manually uploading data. In cases where wifi or ethernet signal is not available, Dickson offers loggers that can download data from them into the DicksonOne portal through our Legacy Uploader tool providing true end to end monitoring everywhere in the supply chain. These kinds of innovations in clinical supply chain management allow quick responses and paths of action to any temperature complications, which can reduce safety risks for patients as well as manufacturing and shipment costs for clients.
Temperature monitoring of medication has become increasingly important with regulation changes that have imposed an increase in what must be monitored, and an increase in complex, highly valuable medication has added to the difficulty of this task. Therefore it is vital that trial staff choose technology that not only reduces extra work, but also provides accurate and complete data on the temperature conditions in which the medicine has been exposed. Using technology that communicates with automatic uploads reduces the time staff needs to spend on temperature monitoring and increases the time spent on patients.
Thanks to DicksonOne, temperature monitoring has been made easy. Visit DicksonData.com to talk to a product specialist today!